Inclusion of MammaPrint reflects growing role of genetic profiling in providing quality care for early stage breast cancer patients in Spain
IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS – DECEMBER 1, 2020 – Agendia, Inc., a world leader in precision oncology for breast cancer, today announced the inclusion of MammaPrint® in the first edition of the ‘Breast Cancer Clinical Pathway’ guidelines and recommendations document published by the Spanish Society of Senology and Breast Pathology (SESPM).
The SESPM’s Clinical Pathway describes structured criteria for the management of patients with suspected breast cancer, the diagnostic confirmation process, and the therapeutic approach. The document also sets out to serve as a useful tool for the continuous improvement of patient care, to reduce unjustified clinical variability and to facilitate regular evaluation so that information is available on key indicators and the assessment and care provided to patients.
The inclusion of Agendia’s 70-gene cancer recurrence assay, MammaPrint, is a welcome acknowledgment of using a precision oncology approach to enable personalized treatment. The SESPM report points to the level 1A clinical evidence provided by the MINDACT de-escalation trial and FDA approval as indicators of the clinical utility of MammaPrint to create a clearer genomic picture.
“Breast cancer is the most common type of cancer affecting women in Spain* and the new SESPM report is a necessary guide to aid healthcare professionals in making clinical decisions throughout the process from initial suspected malignancy through the various treatment options,” said Dr. Laia Bernet Vegué, a pathologist at Hospitales Grupo Ribera Salud and one of the clinical coordinators for the Breast Cancer Clinical Pathways. “The inclusion of gene assays and other predictive and prognostic tests will help physicians determine the genetic profile of a patient’s specific cancer. Indeed, tests such as MammaPrint enable unnecessary treatments to be avoided, allowing patients to retain their quality of life and live long disease-free lives.”
*according to 2019 estimates by the Spanish Network of Cancer Registries (REDECAN)
Agendia is a precision oncology company committed to improving clinical outcomes and informing the journey for patients with early stage breast cancer. The company currently offers two commercially available genomic profiling tests, processed through its state-of-the-art facility in Irvine, California. Agendia also provides a next generation sequencing kit for use by local laboratories outside of the United States.
MammaPrint®, the 70-gene breast cancer recurrence assay, is the first FDA-cleared risk-of-recurrence test backed by peer-reviewed, prospective outcome data and included in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is a commercially available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint and BluePrint provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings. By developing evidence-based, novel genomic tests, Agendia aims to support the evolving clinical needs of breast cancer patients and their physicians.
Agendia's assays can be ordered on core biopsies or surgical specimens with results provided in as little as 5-7 days to inform pre- and post-operative treatment decisions. For more information on Agendia's assays and ongoing trials, please visit www.agendia.com.
About the MINDACT Trial
MammaPrint is supported by the highest level of clinical evidence (level 1A) from MINDACT, a landmark independent trial published in the New England Journal of Medicine in 2016. MINDACT stands for Microarray In Node-Negative and 1-3 node-positive Disease may Avoid ChemoTherapy. It was a phase III, prospective, randomized, clinical study for a breast cancer recurrence test sponsored by the European Organization for Research and Treatment of Cancer (EORTC-10041/BIG3-04).
View trial information here.
Issued for and on behalf of Agendia by Instinctif Partners.
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